Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

This study has been completed.

Sponsor:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00783705

First Posted: November 3, 2008

Last Update Posted: December 5, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.

Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. [ Time Frame: From baseline up to 6 months ]

The definitions of responses are:

Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.

Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. [ Time Frame: From baseline up to 6 months ]

The definitions of responses are:

Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease

Secondary Outcome Measures:

Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment [ Time Frame: From baseline up to 6 months ]

The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.

Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia [ Time Frame: From baseline up to 6 months ]

Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray [ Time Frame: From baseline up to 6 months ]

Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) [ Time Frame: From baseline up to 6 months ]

After completion of study treatment, patients are followed within 30 days.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

45 Years to 79 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria:

Current or former smoker with ≥ a 30 pack-year smoking history and no history of lung cancer

No non-calcified lung nodules ≥ 10 mm diameter on spiral CT scan unless cancer is ruled out by PET/CT scan or by biopsy

ECOG performance status 0-1

Hemoglobin normal

Leukocyte count ≥ 3,000/mm³

Absolute neutrophil count ≥ 1,500/mm³

Platelet count ≥ 100,000/mm³

Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

Alkaline phosphatase ≤ 1.5 times ULN

ALT and AST ≤ 1.5 times ULN

BUN ≤ 1.5 times ULN

Chloride ≤ 1.5 times ULN

Total CO_2 ≤ 1.5 times ULN

Sodium ≤ 1.5 times ULN

Calcium ≤ 1.5 times ULN

Potassium ≤ 1.5 times ULN

Phosphorus ≤ 1.5 times ULN

Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30mL/min

Fasting blood glucose normal

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

No cancer within the past 3 years except stage 0 or I NSCLC, nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was treated > 6 months ago

No concurrent uncontrolled illness including, but not limited to, any of the following: